Kinamed, Inc.: FDA clearances and approvals
Kinamed, Inc. has 33 FDA 510(k) clearances (first 1988, latest 2013), across 14 product codes in 3 review panels. Median 510(k) review time: 89 days. openFDA lists 1 product recall by a recalling firm named Kinamed, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 267 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 12 | 12 |
| HAW | Neurological Stereotaxic Instrument | 4 | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (27)
- Neurology (5)
- Dental (1)
Most recent Kinamed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122049 | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM | GWO | 2013-04-05 | 267 |
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | KTT | 2007-11-09 | 88 |
| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | HAW | 2005-05-24 | 46 |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | HAW | 2004-03-11 | 111 |
| K032950 | GEM INSET PATELLAR COMPONENT | JWH | 2003-12-19 | 88 |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | JDQ | 2003-10-21 | 270 |
| K020764 | NAVIPRO | HAW | 2002-06-03 | 88 |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | KRR | 2002-05-21 | 169 |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | JWH | 2001-05-17 | 126 |
| K003347 | ORTHOPILOT | HAW | 2001-02-23 | 121 |
23 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-08-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kinamed, Inc. have?
Kinamed, Inc. has 33 FDA 510(k) clearances (first 1988, latest 2013), across 14 product codes in 3 review panels.
How long does FDA take to clear Kinamed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kinamed, Inc.'s cleared 510(k)s is 89 days.
What devices does Kinamed, Inc. make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 12); HAW (Neurological Stereotaxic Instrument, 4); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 3).
Has Kinamed, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Kinamed, Inc; the most recent began 2010-08-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 33 Kinamed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZO, Kinamed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.